<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20190121042445N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-07</date_registration>
      <primary_sponsor>Medcare International Hospital</primary_sponsor>
      <public_title>Effects of muscle energy technique in patients with tension type headache on pain , range of motion and functional level</public_title>
      <acronym></acronym>
      <scientific_title>Effects of muscle energy technique in patients with tension type headache on pain , range of motion and functional level</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2640-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/54101</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: A prospective randomized clinical trial study, Randomization description: Participants were selected through Non probability convenient sampling technique as per inclusion and exclusion criteria. Patients of TTH were randomly allocated into 2 equal groups (Group A=24 and Group B=24) and randomization was done by lottery method.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Tension type headache.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group; Muscle Energy Technique on upper trapezius The patient places in a moderate opposed exertion (20% of the accessible solidarity) to convey the decent shoulder to the ear (a shrug movement) and the ear to the shoulder. There ought to be a moderate level of duty and no uneasiness ought to be experienced. The compression goes on for 7-10 seconds and when the exertion is totally loose. Muscle energy technique on sternocleidomastoid Patient is approached to lift a little degree to the roof the completely turned head and to hold the breath. There is no requirement for the professional to apply opposition when the head is raised as this is adequately given by gravity. Between 7-1 0 seconds of isometric constriction, the patient is advised to discharge the exertion (and breath) bit by bit and position the head on the table so that there is a little level of expansion. Moist heating pad is applied for 10 minutes before each session. Protocol 2: Myofascial release technique on upper trapezius The muscle is put on a gentle leeway by moving the ear somewhat to the shoulder on a similar side with the patient recumbent, or presumably sitting. The whole mass of the upper trapezius is raised off the supraspinatus muscle and summit in a pincer grasp. The muscle at that point rolls firmly between the fingers and thumb to palpate for a knob and tight groups to discover Trigger point's spot delicacy. Treatment session longs for 10 minutes of myofascial release on each side. Myofascial release technique on sternocleidomastoid The patient sits in a low-upheld firm-sitting easy chair easily and loose with each hand's fingers snared under the seat or under the thigh. The patient's head might be supported in the administrator's hand to enable the patient to loosen up the neck muscles, with the administrator's head leaning against the administrator's arm or chest. The patient is encouraged to rest the administrator's head weight and utilize greatest profound stomach breathing, which likewise unwinds. Therapist applies pressure on trigger points located in sternal and clavicular divisions of muscle with pincer grip. Gradually increasing the pressure and releasing the trigger points one by one. This is followed by stretching of muscle by deep inhalation, rotation of head on opposite side and rotation of chin on same side. Treatment session longs for 10 minutes of myofascial release on each side. Intervention 2: Control group: Treatment applied in this group is myofascial release technique for upper trapezius and sternocleidomastoid muscle. This was applied in the same way mentioned in the protocol 2 of  intervention no. 1.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Individual participant data will not be shared to others as it is my personal property</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Akhtar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>gujranwala</address>
        <city>Gujranwala</city>
        <country1>Pakistan</country1>
        <zip>52200</zip>
        <telephone>+92 55 3732032</telephone>
        <email>a.hunjra@gmail.com</email>
        <affiliation>Medcare International Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Akhtar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gill Road</address>
        <city>Gujranwala</city>
        <country1>Pakistan</country1>
        <zip>52200</zip>
        <telephone>+92 55 3732032</telephone>
        <email>a.hunjra@gmail.com</email>
        <affiliation>Medcare International Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients of both gender of age 18-40 years with diagnosis of ETTH and CTTH were included
At least 10 episodes occurring on ≥1 day per month for at least 3 months
Headache episodes lasting from 30 minutes to 7 days</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>48 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with Headache that is aggravated by head movements, musculoskeletal and metabolic disorders with symptoms homogenous to headache (rheumatoid arthritis), previous neck trauma, Vertigo, dizziness, arterial hypertension, Malignancy, infection, trauma, bone deformities were excluded from the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group; Muscle Energy Technique on upper trapezius The patient places in a moderate opposed exertion (20% of the accessible solidarity) to convey the decent shoulder to the ear (a shrug movement) and the ear to the shoulder. There ought to be a moderate level of duty and no uneasiness ought to be experienced. The compression goes on for 7-10 seconds and when the exertion is totally loose. Muscle energy technique on sternocleidomastoid Patient is approached to lift a little degree to the roof the completely turned head and to hold the breath. There is no requirement for the professional to apply opposition when the head is raised as this is adequately given by gravity. Between 7-1 0 seconds of isometric constriction, the patient is advised to discharge the exertion (and breath) bit by bit and position the head on the table so that there is a little level of expansion. Moist heating pad is applied for 10 minutes before each session. Protocol 2: Myofascial release technique on upper trapezius The muscle is put on a gentle leeway by moving the ear somewhat to the shoulder on a similar side with the patient recumbent, or presumably sitting. The whole mass of the upper trapezius is raised off the supraspinatus muscle and summit in a pincer grasp. The muscle at that point rolls firmly between the fingers and thumb to palpate for a knob and tight groups to discover Trigger point's spot delicacy. Treatment session longs for 10 minutes of myofascial release on each side. Myofascial release technique on sternocleidomastoid The patient sits in a low-upheld firm-sitting easy chair easily and loose with each hand's fingers snared under the seat or under the thigh. The patient's head might be supported in the administrator's hand to enable the patient to loosen up the neck muscles, with the administrator's head leaning against the administrator's arm or chest. The patient is encouraged to rest the administrator's head weight and utilize greatest profound stomach breathing, which likewise unwinds. Therapist applies pressure on trigger points located in sternal and clavicular divisions of muscle with pincer grip. Gradually increasing the pressure and releasing the trigger points one by one. This is followed by stretching of muscle by deep inhalation, rotation of head on opposite side and rotation of chin on same side. Treatment session longs for 10 minutes of myofascial release on each side.</i_keyword>
      <i_keyword>Control group: Treatment applied in this group is myofascial release technique for upper trapezius and sternocleidomastoid muscle. This was applied in the same way mentioned in the protocol 2 of  intervention no. 1.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: baseline, 4th and 8th weeks since intervention. Method of measurement: Numerical pain Rating scale (NPRS).</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: baseline, 4th and 8th weeks since intervention. Method of measurement: Inclinometer is used to assess cervical range of motion.</prim_outcome>
      <prim_outcome>Functional level. Timepoint: baseline, 4th and 8th weeks since intervention. Method of measurement: Headache disability index and headache impact test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Medcare International Hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2640-09-22</approval_date>
        <contact_name>Medcare International Hospital</contact_name>
        <contact_address>Nil Gujranwala Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
